Siemens IMMULITE 2000 BR-MA

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SIEMENS HEALTHCARE PTE. LTD.

Class:

Class C IVD

Manufactured by:

Siemens Healthcare Diagnostics Products Limited

Therapeutic area:

Immunology

Therapeutic indications:

It is for in vitro diagnostic use with the IMMULITE® 2000 analyzers – for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in stage II and stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.

Product summary:

Models: IMMULITE 2000 Systems BR-MA - L2KBR2, BR-MA Test Units - LBR1, BR-MA Reagent Wedges - LBRA, BR-MA Reagent Wedges - LBRB, BR-MA Adjustors - LBRL, BR-MA Adjustors - LBRH, BR-MA Sample Diluent - LBRZ, BR-MA Bead Pack - L2BR12, BR-MA Reagent Wedges - L2BRA2, Multi-Diluent 2 - L2M2Z, Multi-Diluent 2 - L2M2Z4

Authorization date:

2013-09-20